Clinical Trials Logo
  1. Home
  2. Locally Advanced Solid Tumor
  3. NCT03284502

HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors

Metastatic Solid Tumor Clinical Trial

Official title:
A Phase Ib, Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Summary

This study evaluates the safety, tolerability and pharmacokinetics of HM95573 In combination with either cobimetinib or cetuximab in patients with locally advanced or metastatic solid tumors.

Clinical Trial Description

This is a Phase Ib, open-label, multicenter dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral dosing of HM95573 in combination with either cobimetinib or cetuximab in patients with histologically/cytologically confirmed, locally advanced, or metastatic solid tumors with RAS- or RAF-mutation for which standard therapies either do not exist or have proven ineffective or intolerable. Treatment will continue until disease progression, unacceptable toxicity, any other discontinuation criterion is met. There are two stages of this study: Stage 1 and 1b, standard 3+3 dose escalation, and Stage 2, an indication-specific dose expansion. Stage 1 is designed to establish the combination MTD for cobimetinib and HM95573. Stage 1 consists of concurrent administration of cobimetinib and HM95573. Stage 1b, is designed to select the combination dose of cetuximab and HM95573 for expansion stage. In Stage 2 expansion cohort I and II, the RD of cobimetinib and HM95573 with different dosing schedules or regimens might be investigated (which may be≤ MTDs established during dose escalation) in indication-specific expansion cohorts. Stage 2 expansion cohort III will further characterize the safety and tolerability of cetuximab in combination with HM95573. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03284502
Study type Interventional
Source Hanmi Pharmaceutical Company Limited
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 22, 2017
Completion date December 31, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT05071183 - A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT05530200 - PRaG Regimens Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors. Phase 2
Active, not recruiting NCT04447651 - Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)
Recruiting NCT04419532 - A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT04137900 - Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies Phase 1
Recruiting NCT04585750 - The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) Phase 1/Phase 2
Not yet recruiting NCT05028478 - A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies Phase 1/Phase 2
Recruiting NCT05867121 - A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05471271 - IL-2 PET Imaging in Advanced Solid Tumours N/A
Active, not recruiting NCT03964727 - Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors Phase 2
Recruiting NCT06108050 - JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors Phase 1
Recruiting NCT05688280 - Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS Phase 1/Phase 2
Completed NCT04914117 - A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours Phase 1
Completed NCT00997529 - Mini Allo Stem Cell Transplantation for the Treatment of Solid Tumors N/A
Recruiting NCT04614740 - The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06163391 - A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer Phase 1
Not yet recruiting NCT06415487 - ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) Phase 1